All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

OBX-115 Elicits Responses in Advanced or Metastatic Melanoma

December 16th 2023

The tumor-infiltrating lymphocyte cell therapy OBX-115 produced responses with no dose-limiting toxicities in heavily pretreated patients with advanced or metastatic melanoma whose who had progressed on anti–PD-1 and anti–CTLA-4 therapy with disease that was primary-resistant to immune checkpoint inhibitor therapy.

Shitara and Xu Discuss Potential FDA Approval of Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma

December 15th 2023

Rui-Hua Xu, MD, PhD, and Kohei Shitara, MD, expand on the advantages of targeting CLDN18.2 with zolbetuximab in gastric/GEJ adenocarcinoma and key efficacy data from the GLOW and SPOTLIGHT trials in support of zolbetuximab’s potential FDA approval.

Oral CELMoD Mezigdomide May Address Logistical Challenges Linked With R/R Myeloma Management

December 15th 2023

Paul G. Richardson, MD, shares clinical findings and several case studies showcasing the encouraging activity and safety of mezigdomide in patients with relapsed/refractory multiple myeloma.

FDA Approves Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer

December 15th 2023

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

RCC Research May Lead to SOC Improvements and Individualized Treatment Plans

December 15th 2023

Marijo Bilusic, MD, PhD, highlights key insights about renal cell carcinoma that were presented at the meeting covering considerations on sequencing TKIs, the need for further research to elucidate novel therapies, and the importance of offering clinical trials to all patients with genitourinary malignancies.

Pembrolizumab Plus Lenvatinib Misses Both Survival End Points in Advanced, Recurrent Endometrial Cancer

December 15th 2023

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.

FDA Grants Fast Track Status to Naporafenib Plus Trametinib for Advanced NRAS-Mutated Melanoma

December 15th 2023

The FDA has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.

Zanubrutinib Favored Over Bendamustine/Rituximab Combination Across Biomarker Subgroups in CLL/SLL Without del(17p)

December 15th 2023

Treatment with zanubrutinib conferred a PFS benefit vs bendamustine plus rituximab across most biomarker subgroups of patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma without del(17p), according to findings from the phase 3 SEQUOIA trial.

FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

December 14th 2023

The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI.

Acquired BTK and PLCG2 Mutations May Not Drive Progression After Zanubrutinib/Ibrutinib Treatment in Relapsed CLL

December 14th 2023

The majority of patients with relapsed CLL treated with zanubrutinib or ibrutinib in the phase 3 ALPINE study did not acquire a BTK or PLCG2 mutation at the time of disease progression, indicating that these mutations may not be the primary drivers of resistance and relapse in this population.

RP1 Plus Cemiplimab Misses Response End Points in Locally Advanced or Metastatic CSCC

December 14th 2023

The combination of RP1 and cemiplimab provided a numerical, but not statistically significant, improvement in response rates vs cemiplimab alone in patients with locally advanced or metastatic cutaneous squamous cell carcinoma, missing the primary end points of the phase 2 CERPASS trial.

Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma

December 14th 2023

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Frontline IO/TKI Regimens Continue to Evolve in ccRCC

December 14th 2023

Jaime R. Merchán, MD, discusses the evolution and current role of IO/TKI regimens in advanced RCC; highlights data from the phase 3 CLEAR and KEYNOTE-426 trials supporting the use of pembrolizumab-based regimens in untreated ccRCC; and speculates on how future biomarker-driven research could improve the benefit seen with these combinations in this disease.

FDA Grants Priority Review to Tarlatamab for Small Cell Lung Cancer

December 14th 2023

The FDA has accepted and granted priority review to the biologics license application seeking the approval of tarlatamab for the treatment of patients with advanced small cell lung cancer.

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health to Showcase Expansive Portfolio of Hematology/Oncology Data at the 65th American Society of Hematology Annual Meeting and Exposition

December 14th 2023

Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health will present an extensive array of hematology/oncology data from their clinical research program at the 65th American Society of Hematology Annual Meeting and Exposition, being held in San Diego, California from December 9-12, 2023.

Neoadjuvant KN026 Plus Docetaxel Demonstrates Early Activity in HER2+ Breast Cancer

December 14th 2023

The novel bispecific antibody KN026 and docetaxel elicited responses with an acceptable toxicity profile when administered as neoadjuvant treatment in patients with HER2-positive early or locally advanced breast cancer.

Dostarlimab Plus Chemo Granted EU Approval for dMMR/MSI-H Endometrial Cancer

December 14th 2023

The European Commission has granted marketing authorization to dostarlimab paired with carboplatin and paclitaxel in adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are eligible to receive systemic treatment.

FDA Approves Eflornithine for Adult, Pediatric Patients With High-Risk Neuroblastoma

December 13th 2023

The FDA has approved eflornithine (Iwilfin) as a treatment to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have achieved at least a partial response to prior multi-agent, multimodality therapy including anti-GD2 immunotherapy.

Responses With Pirtobrutinib Remain High Despite Acquired Resistance in Relapsed CLL/SLL

December 13th 2023

Responses on the non-covalent BTK inhibitor pirtobrutinib remained high in patients with relapsed chronic lymphocytic leukemia who expressed frequent baseline BTK mutations, according to a genomic analysis of the phase 1/2 BRUIN trial.

Biomarker Data and Patient Preference Inform Perioperative Therapy Selection in Early HER2+ Breast Cancer

December 13th 2023

Maria Hafez, MD, discusses factors such as HER2 status, lymph node negativity, and risk stratification that influence the selection of adjuvant treatment approaches for patients with early-stage HER2-positive breast cancer and expands on pivotal data that have changed the paradigm.